Neuropathic PainPhase 2NCT00736151
Phase II Dose Titration Study in Patients With Neuropathic Pain
A Phase 2 study testing Ralfinamide in people with Neuropathic Pain, run by Newron Pharmaceuticals SPA at 47 sites in 6 countries.
Trial summary
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Ralfinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 47 sitesin 6 countries
- Study dates
- May 2004to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients
- Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria
- Diagnosed by neurologist with current neuropathic pain
Who cannot join
- See inclusion criteria
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
Italy15 sites
Ospedali Riuniti di Bergamo
Bergamo
Ce. S.I. Fondazione Universitaria
Chieti
Ospedale Clinicizzato Universitario SS. Annunziata
Chieti
Arcispedale Sant'Anna
Ferrara
Azienda Ospedaliera San Martino
Genova
Universita degli Studi di Genova
Genova
Ospedale Luigi Sacco
Grassi
Ospedale Civile Umberto I
Mestre
Ospedale San Raffaele
Milan
Istituto Scientifico di Riabilazione di Montescano
Montescano
Policlinico Universitario Federico II
Naples
UCADH
Pavia
Presidio Ospedaliero Monteluce
Perugia
Universita degli Studi di Roma
Roma
Policlinico G.B. Rossi
Verona
India10 sites
Neurology Centre
Ahmedabad
M.S. Ramaiah Medical
Bangalore
R.S. R'S Trinity Acute Care Hospital
Chennai
Sri Ramachandra medical College
Chennai
Care Hospital
Hyderabad
Chowpatty Medical Centre
Mumbai
Brain and Mind Institute
Nagpur
Apollo Hospital
Pradesh
Brain Waves Clinic
Pune
Vijaya Health Centre
Vadapalani
Poland8 sites
Centrum Medyczne Osteomed
Bialobrzeska
Centrum Kliniczno Badawcze
Elblag
Wojewodzki Szpiyal Spejalistyczny
Gdansk
Center Of Clinical Neurology
Krakow
Osrodek Baden Klinicznych
Lublin
Wojskowy Instytut Medyczny
Warsaw
Wroclaw Medical University
Wroclaw
Oddzial Neurologiczny
Zgierz
Czechia6 sites
Fakultni nemocnice u svate' Anny v Brne
Brno
Fakultni nemocnice Brno
Brno-Bhunice
University Hospital Olomouc
Olomouc
Univercity Hospital Pilsen
Pizen
Fakultni Thomayerova nemocnices poliklinikou
Prague
Na Homolce Hospital
Prague
Austria4 sites
Universitatsklinik Fur Neurologie
Graz
Universitatsklinik Fur Neurologie
Innsbruck
LKH
Klagenfurt
General Hospital AKH
Vienna
United Kingdom4 sites
Gartnavel General Hospital
Glasgow
Barta and The London NHS Trust
London
Kings College Hospital
London
Solihull Hospital
West Midlands
About this study
Official title: A Phase II, Multicentre, Pilot, Randomised, Double Blind Placebo Controlled Dose Titration Study to Evaluate the Safety, Maximum Tolerated Dose and Preliminary Evidence of Efficacy of Orally Administered Ralfinamide at Four Doses (80, 160, 240 and 320 mg/Day) in Patients With Neuropathic Pain
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.
- Conditions
- Neuropathic Pain
- Being tested
- Ralfinamide
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RalfinamideDrug
Oral tablets administered at rising doses of 80 - 320 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ralfinamide administered orally at rising doses of 80 - 320 mg/day Receives: Drug: Ralfinamide |
| 2 | Active comparator | Placebo controlled with randomization of 2:1 Receives: Drug: Ralfinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain intensity
Measured: Baseline to week 8 or last visit
Secondary outcomes (1)
The incidence of adverse events
Measured: From baseline to week 8 or last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startMay 2004
- Primary completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736151
- Sponsor's protocol ID
- NW-1029/001/II/2003
- Other IDs
- EUDRACT Number 2004-000557-35
- Status last verified
- Aug 2009
- First submitted
- 13 Aug 2008
- Last updated
- 7 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Pilot, Randomised, Double Blind Placebo Controlled Dose Titration Study to Evaluate the Safety, Maximum Tolerated Dose and Preliminary Evidence of Efficacy of Orally Administered Ralfinamide at Four Doses (80, 160, 240 and 320 mg/Day) in Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00736151
- Acronym / sponsor ID
- NW-1029/001/II/2003
- Conditions
- Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Apr 2007 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RalfinamideRalfinamide administered orally at rising doses of 80 - 320 mg/day |
| 2 | Active comparator | Drug: RalfinamidePlacebo controlled with randomization of 2:1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients
- Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria
- Diagnosed by neurologist with current neuropathic pain
Key exclusion criteria (1 listed)
- See inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RalfinamideOral tablets administered at rising doses of 80 - 320 mg/day | Drug | 1, 2 |
Primary outcome
Change of pain intensity
Time frame: Baseline to week 8 or last visit
1 secondary outcome
The incidence of adverse events
Time frame: From baseline to week 8 or last visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ralfinamide in people with Neuropathic Pain, run by Newron Pharmaceuticals SPA at 47 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Italy, India, Poland, Czechia, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain intensity (time frame: Baseline to week 8 or last visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.